| Primary Device ID | 00033732000079 |
| NIH Device Record Key | 81108602-eea9-4ad0-9cc9-982e53b6f7fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mack's |
| Version Model Number | Pillow Soft Silicone Putty Earplugs |
| Catalog Number | 7 |
| Company DUNS | 006522122 |
| Company Name | McKeon Products, Inc. |
| Device Count | 12 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |